Our piece[1] on new approaches to consumer healthcare claims and real-world outcomes data was read by over 2000 people, thanks!!

Several weeks have passed and we thought it would be interesting to share some of the questions/discussions and insight it generated.

Overall, healthcare marketers seem to share our optimism – the approach has legs. But, we would like more input from our clinical/regulatory colleagues, so don’t be shy! The whole point is to create collaboration across disciplines and experience tells us you will add value. Key inputs so far:

Hybrid approach. To the previous point, everyone agreed that it requires a ‘hybrid’ approach blending the best qualities of clinical study and data expertise alongside hands-on commercial/marketing and ‘innovation’ experience. Most also felt this was, if not unique, different from most available input. People shared personal stories of ‘clinical’ work that lacked the behavioural insight required to deliver commercial value and creative/ideation approaches that simply did not understand or failed to meet the technical/clinical hurdles the business/regulators needed to be truly ‘usable’. Or people who offered both, but lacked the suite of skills.

One ‘killer’ question keeps popping up. It’s a good one, it goes like this…

‘Ok. So, I get that we can drive strong communications claims in a market like the UK, but will this approach produce data that can go on the label and therefore be used in other markets and/or go on the pack’.

Honest answer. This is tough!!! Given the ‘boxes’ on the standard SPCs/PILs in Europe it is hard to see where to physically put PROM-type data [another example of the regulatory approach not really matching self-medication needs given that these data could potentially be helpful to consumers/patients making choices.]

The Wirkungsweisebox on a German label, for example, where the data that explains what the drug does is presented, could theoretically include other useful usage information on the ‘operation’ of the product in the ‘real world’ beyond the ingredient modes of action. But, we all know this runs counter to the philosophical position of most regulators.

That said, since the output will be robust, well produced [to clinical standards], published data and a well-run project would produce a data-set, not a single paper it has the potential to pass the basic acceptance hurdles of the regulators/clinicians and be worthy of discussion.

Big Pharma is not using PROM on labels, though they are using it for serious purposes with regulators/government to explain value/justify pricing and show differences/patient benefits in an attempt to influence prescribing behaviour.

In effect, that is similar to the aim here – to show brand difference/distinctiveness to influence choices via robust, supportable data/claims – but, we need the data be ‘publicly’ usable with people not just used in-camera with HCPs. Currently, in most of Europe, that needs it to be on the label.

So to be honest this requires a brand owner to run up the hill, innovate and have the patience to ‘work with the authorities’ to get relevant data on the label and build a test case. This is a long-term commitment with no guarantee of success. But, we struggle to see what the alternative is for brands? If they do not take on the challenge of changing regulations to facilitate better self-medication and more marketing they are on a long, slow slippery slope to a universe filled with Amazon own-label!!

The industry should [and it isn’t really] tackle the fundamental challenges around the ‘future of self-medication’. Our small innovation is at the heart of this. We [brands/own label/generics etc.] need self-medication labelling regulation etc. that is specifically designed for self-medication, not a sub-set of Rx with its completely different needs/safety issues. WE DO NOT CURRENTLY HAVE THIS… industry needs to take a deep breath and FIGHT FOR IT! Yes, it’s better than it was, but…

So, creating a box on the label outlining relevant, proven, robust behavioural data outlining how people using the brand/product in the pack they have bought or are thinking of buying have got best results or positive outcomes – including PROM studies – seems relevant. Dare we say… helpful even! It is part of the need to put people at the heart of healthcare and explain the benefits [not just the actions] of the product to people to enable them to see its relevance. Yes, this is marketing, but as long as it is based on good data and it all happens on a level playing field [e.g. companies that invest in the data can protect it] and own label/generics can play too, where is the issue?

OTHER STUFF…

Evidence Portfolios. The idea of building a brand specific [owned] data set versus a single study approach also resonated – we call this evidence portfolio creation.[2]It is what R&D plans to do anyway, yet, when we review our own experience of OTC clinical work (infrequent as it is) we have seen little evidence of the approach we propose. We rarely focus data creation on the end user outcomes and using that to build a multi-layered portfolio of evidence seeded in public domain and cross referenced to maximum effect. Data is usually targeted against a specific need. Nothing wrong with that, but it might not be optimising the opportunity of the investment. We are perhaps most excited about the potential to repurpose and add value to this existing data – it seems a cost-effective shot to nothing!

Many people felt this was a big behavioural change for brands/marketing who see communications as an ‘FMCG’ consumer/emotional engagement task – and it is – but this usually positions data/claims as ‘content’ to improve their ads. Since we usually advertise our NPD this can make it very short term. To start with a consumer experiential model to drive relevance and distinctiveness is a big change requiring investment decisions/changes. That said, real world outcome claims around NPD sounds like a good idea.

Social media? Lots of cynical questions about the use of social media data to build a quantitative frame of reference. What the discussion showed is [apologies to anyone who thinks we might mean them!] how little marketers understand about the potential of these data. Clinicians understand even less. Done properly this is a massively valuable input. Don’t imagine this would be a bit of blunt, possibly interesting, but completely unactionable slice of social-listening data. We see lots of this, and apologies to clients who do it, but save your money. Clever people with proprietary approaches, mashing together multiple data sources and using/analysing the data and connections are producing some of the most powerful insight, influence and targeting work we’ve ever seen[3]!

Methods? Lots of questions on methods etc. firstly, it isn’t off the shelf, so it is hard to put into a box. But, since none of the basic methods – sample creation; mobile data capture; questionnaires; product use; statistical analysis etc. etc. are ‘new’ – it’s the packaging up and outputs that are innovative – we don’t see this as the area for debate. If we set up and agree outcomes the study/trial will behave in a similar way to other work you’ve done. It’s the outputs that are different, based on a fresh way of looking at data and how they work.

How much will it cost? Lots of questions on cost. How long is a piece of string? As said, definitely much cheaper than full scale clinical work and with a better PTS; more expensive than a few workshops for sure. Two comments… the journey can be started slowly [i.e. proof of principle before a major study] and the ‘pre-work’ gives you a milestone to say go/no-go before the button is pressed whilst building a powerful input on your existing claims potential/landscape. You can even write up and publish the pre-work! In the end, having done claims work for a few decades now, we have a reasonably high confidence on some ROI.

Again, we think the answer is to talk about this stuff in the context of specific needs vs theoretical constructs. We’d rather jump through a few hoops to demonstrate the value than write articles; in reality a few documents and blogs are frankly irrelevant versus a SPECIFIC exploration/discussion of your brands and categories.